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Synbiotics Interventions for Managing Cirrhosis and Its Complications

NCT05687409 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-01-18

No results posted yet for this study

Summary

Background Liver cirrhosis is commonly accompanied by intestinal dysbiosis and metabolic defects. Many clinical trials have shown microbiota-targeting strategies represent promising interventions for managing cirrhosis and its complications. However, the influences of the intestinal metagenomes and metabolic profiles of patients have not been fully elucidated.

Methods administered lactulose, Clostridium butyricum, and Bifidobacterium longum infantis as a synbiotic and used shotgun metagenomics and non-targeted metabolomics to characterize the results.

Conditions

  • Cirrhosis, Liver
  • Metagonimiasis

Interventions

DRUG

Entecavir 0.5 mg

Orally administered Entecavir 0.5 mg, once a day. For six months

DRUG

A 10-g packet of lactulose oral solution and three capsules of probiotics

A 10-g packet of lactulose oral solution and three capsules of probiotics (each containing \> 4.2×106 CFU Clostridium butyricum and \> 4.2×105 CFU Bifidobacterium longum infantis). Participants orally administered the contents three times daily after meals. For six months.

DIETARY_SUPPLEMENT

A 10-g packet of glucose oral solution and three capsules of starch

A 10-g packet of glucose oral solution and three capsules of starch. Participants orally administered the contents three times daily after meals. For six months.

Sponsors & Collaborators

  • First Affiliated Hospital of Zhejiang University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-24
Primary Completion
2021-05-24
Completion
2022-10-24

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05687409 on ClinicalTrials.gov